Chronic Low Back Pain: A Multidisciplinary Approach

Chronic Pain Clinical Trial

— CLBP-HUVH  

Official title:

A Multidisciplinary Approach to Treat and Rehabilitate Patients With Chronic Low Back Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01993355
• Other study ID #: CLBP-PT_ATR_274-2012
• Status: Completed
• Phase: N/A
• First received: November 11, 2013
• Last updated: June 15, 2015
• Start date: March 2013
• Est. completion date: January 2015

Study information

• Verified date: June 2015
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Hospital Universitari Vall d'Hebron Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Introduction: Non-specific chronic low back pain (CLBP) is one of the most frequent causes for patient disability and a general recurrent cause for medical consultation with high costs to public health. From rehabilitative medicine, physiotherapy is commonly offered. Although this treatment is aimed to reduce disability, pain severity and pain-related anxiety-depressive symptoms, many patients report partial improvement and recurrent intensive and disabling pain episodes. Therefore, a new approach in the treatment and rehabilitation of this pathology that takes into account psychosocial aspects that might be modulating pain is necessary.

Material and methods: This project aims to assess the efficacy of two complementary interventions to standard physical therapy, such as relaxation techniques and cognitive-behavioral intervention, to improve health-related quality of life (HRQoL) among patients with CLBP. It is hypothesized that groups receiving these complementary interventions will significantly improve their adherence to physiotherapy and the control of their pain and, ultimately, these aspects will facilitate a decreasing of pain intensity and better HRQoL.

For these purposes, a pre-post longitudinal design will be carried out, with follow-up assessments at 6 and 12 months in a sample of 66 participants. This sample will be divided into: control group (physiotherapy), intervention group 1 (physiotherapy and relaxation techniques-sophrology) and intervention group 2 (physiotherapy and cognitive-behavioral intervention).

Expected impact: Study results are not available yet. However, if working hypotheses are confirmed, a multidisciplinary model of care for CLBP will be empirically justified. This approach is expected to benefit HRQoL among these patients implying a significant short-mid term reduction of public health costs.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: January 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

Inclusion Criteria:

• Non-specific chronic (> 6 months of evolution) low back pain diagnosis

• Ability to read and speak in Spanish

Exclusion Criteria:

• Addictive behaviors (DAST-10 > 3, alcoholism, drug addiction or other drug abuse)

• Psychiatric contraindications (BDI > 15 or other severe psychiatric disorder not stabilized)

• Neurological impairment

• No mental competence (MEC < 23)

• Fibromyalgia and/or chronic fatigue

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Back Pain
• Chronic Pain
• Low Back Pain

Intervention

Other:
• Physiotherapy
Physical therapy exercise program for CLBP patients. Its goal is to reduce pain and improve patients' health-related quality of life, functional capacity and well-being.
• Intervention 1
Relaxation techniques-sophrology consists of a set of physical and relaxation exercises that include breathing methods, visualization, modification of states of consciousness, etc. with the goal to enhance balance between body and mind to improve health-related quality of life, reduce pain and foster patients' well-being.

Behavioral:
• Intervention 2
Cognitive-behavioral therapy (in combination with motivational interviewing principles) is aimed to facilitate psychological adjustment and self-management of CLBP with the ultimate goal of increasing patients' health-related quality of life and well-being.

Locations

Country	Name	City	State
Spain	Hospital Universitari Vall d'Hebron Institut de Recerca Vall d'Hebron	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute

Country where clinical trial is conducted

Spain, 

References & Publications (3)

Castellano-Tejedor, C., Costa-Requena, G., Lusilla-Palacios, P., Barnola-Serra, E. Calidad de vida en pacientes con dolor lumbar crónico: efectos de un programa de intervención multidisciplinar a los 6 meses de seguimiento. Comunicació tipus pòster presen

Castellano-Tejedor, C., Costa-Requena, G., Lusilla-Palacios, P., Biedermann-Villagra, T., Barnola-Serra, E. Calidad del sueño en pacientes con lumbalgia crónica inespecífica. Rehabilitación 48(4): 219-225, 2014. DOI: 10.1016/j.rh.2014.05.003

Group of pain for patients with chronic low back pain: A multidisciplinary intervention. Lusilla-Palacios, P, Castellano-Tejedor, C, Barnola-Serra, E, Ramos-Rondón, C, Biedermann-Villagra, T, Torrent-Bertran, M.L, Costa-Requena, G, Camprubí-Roca, L, Palacios-González, A, Cuxart-Fina, A, Ginés-Puertas, A, Bosch-Graupera, A. Poster communication on the 21th European Congress of Psychiatry, Nice, France, 25-29/05/2010.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	LISAT-8	The LISAT is a domain-specific measure of life satisfaction, which corresponds to Box E (subjective evaluations and reactions; life satisfaction) of Dijker's Model.	Baseline, 6 and 12 months	No
Other	STAI	The State-Trait Anxiety Inventory (STAI) is a commonly used measure of trait and state anxiety. It can be used in clinical settings to screen anxiety and to distinguish it from depressive syndromes.	Baseline, 6 and 12 months	No
Other	BDI-13	The Beck Depression Inventory (BDI) is a 13-item (short-form), self-report rating inventory that measures characteristic attitudes and symptoms of depression.	Baseline, 6 and 12 months	No
Other	PSQI	The Pittsburgh Sleep Quality Index (PSQI) assesses sleep quality during the previous month.	Baseline, 6 and 12 months	No
Other	CAD	The CAD (Cuestionario para el Afrontamiento al Dolor) is a coping questionnaire to chronic pain developed in a Spanish sample.	Baseline and 12 months	No
Other	TAS-20	The Toronto Alexithymia Scale (TAS) 20-item is one of the most commonly used measures of alexithymia (people who have trouble identifying and describing emotions and who tend to minimise emotional experience and focus attention externally).	Baseline and 12 months	No
Other	PSS-14	The Perceived Stress Scale (PSS) is a 14-item questionnaire that measures the degree to which life events are considered stressful.	Baseline and 12 months	No
Other	DUKE-11	The DUKE 11-item social support questionnaire measures an individual's perception of the amount and type of personal social support. The original instrument included 14 items, grouped into 4 subscales: Quantity of Support, Confidant Support, Affective Support, and Instrumental Support.	Baseline and 12 months	No
Other	VAS for patient satisfaction with treatment received	Visual Analogue Scale to rate patients' satisfaction with treatment, attention received and outcomes.	Baseline, 6 and 12 months	No
Other	Medical and demographics	Medical (medical and psychopathological history, physical exploration of LBP and possible substance abuse or other toxic habits such as alcohol or tobacco) and demographics (age, gender, immediate family network, education, job and SES) of patients are collected according to standard procedures.	Baseline	No
Primary	The SF-12v2 Health Status Questionnaire (change is being assessed)	The SF-12 measures health-related quality of life including items from various domains both physical and psychological.	Baseline, 6 and 12 months	No
Secondary	VAS for Self-perceived Pain	Visual Analogue Scale to rate self-perceived pain. Recall period: last 4 weeks.	Baseline, 6 and 12 months	No
Secondary	Oswestry-15 Disability Index	The Oswestry Disability Index (aka: Oswestry Low Back Pain Disability Questionnaire) is a time-tested outcome assessment tool that is used to measure a patient's impairment and quality of life (i.e., how badly the pain has affected their life).	Baseline, 6 and 12 months	No